Rupex 5mg/5ml

Oral Solution
Rupatadine Fumarate
Incepta Pharmaceuticals Ltd

Other Strength:
- Rupex 10mg

Alternative:
- Duvent 5mg/5ml
- Rosela 5mg/5ml



Rupex
Presentation
Rupex tablet: Each tablet contains Rupatadine Fumarate INN equivalent to Rupatadine 10 mg.

Rupex syrup: Each 5 ml syrup contains Rupatadine Fumarate INN equivalent to Rupatadine 5 mg.

Description
Rupex is a preparation of Rupatadine. Rupatadine is a new selective histamine H1 receptor and platelet-activating factor (PAF) antagonist. Rupatadine has dual mechanism of action. It acts as a long-acting, non-sedative antagonist at histaminergic H1-receptor and also antagonizes the platelet-activating factor (PAF). This dual mechanism of action gives Rupatadine a major clinical efficacy.

Indications
Rupex is indicated for the symptomatic treatment of seasonal & perennial allergic rhinitis and idiopathic urticaria.

Dosage & Administration
Adults and adolescents (above 12 years): 10 mg (one tablet) once daily, with or without food.
Elderly (above 65 years): Rupatadine should be used with caution in elderly. No information is available that indicates the requirement of any dose adjustment for this group of patient.
Children: Use of Rupatadine is not recommended in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended.
Rupex Syrup:
Children aged 2 to 11 years:
Children weighing 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) syrup once a day with or without food.
Children weighing 25 kg or more: 1 teaspoonful (5ml) of syrup once a day with or without food.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended.

Side Effects
Rupatadine is a non-sedating antihistamine. However, as in other non-sedating second generation antihistamines, the most common side effects may be somnolence, headache and fatigue.

Use in Pregnancy & Lactation
Pregnancy: Pregnancy category B2. Available limited data showed no adverse effect of Rupatadine on pregnancy or the fetus/newborn child. Since data are not sufficient, pregnant women should use Rupatadine if the expected benefits outweigh the potential risk to the mother and child.
Lactation: No information is available, whether Rupatadine is excreted in the mother's milk. Therefore, it should be used during lactation if the potential benefits outweigh the potential risk to the mother and child.

Drug Interaction
Inhibitors of CYP3A4 may decrease the metabolism of Rupatadine. As in the case of other anti-histamines, the interactions with CNS depressants cannot be excluded.

Over Dose
An accidental consumption of very high dose should be treated symptomatically together with the necessary supportive measures.

Commercial Pack
Rupex Tablet: Each box contains 3 blister strips of 10 tablets.
Rupex syrup: Each bottle contains 60 ml syrup


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